USDA, FDA should more effectively coordinate to manage arsenic levels in rice

Evidence shows that arsenic can be harmful to human health and may be present in water and certain foods, such as rice. Because the safety and quality of the U.S. food supply is overseen by multiple agencies, it is important that the agencies are able to work together to assess threats such as the risk of arsenic in rice. The Government Accountability Office (GAO) conducted a study to determine the risk of arsenic in rice and how well agencies are working together to identify, assess, monitor, communicate, and respond to these risks. The report found that the agencies need to improve coordination in order to develop methods to better detect food borne contaminants, including arsenic (GAO Report, GAO-18-199, April 16, 2018).

Risks. In 2013, the National Research Council (NRC) reported evidence of causal associations between long-term ingestion of arsenic from water or dietary sources, such as rice, and adverse human health effects including skin lesions, skin cancer, lung cancer, cardiovascular disease, and bladder cancer. The NRC also reported that there was some moderate evidence of association between the long-term ingestion of various levels of arsenic from water or dietary sources such as rice and other adverse health effects such as neurodevelopmental toxicity and pregnancy outcomes related to infant illness, disease, or injury, as well as an association to liver and pancreatic cancer and renal disease. The GAO analyzed 14 scientific reviews published since NRC’s report and found that they generally supported NRC’s conclusions.

Agency action. The agencies have identified the risk of arsenic in rice through the FDA’s Total Diet Study and the USDA’s national research programs. The FDA conducted a study and issued a risk assessment of arsenic in rice for public comment in 2016, and USDA agencies have conducted research to develop faster and less expensive methods to detect inorganic arsenic in rice. The FDA has issued a draft guidance recommending that the rice industry not exceed a level of 100 ppb inorganic arsenic in infant cereal, and it conducted research on cooking methods that may reduce arsenic, while the USDA has sponsored published and ongoing research that can help respond to the risk.

Risk of arsenic is monitored by the FDA through its compliance program which is monitors products that are most likely to contribute to the dietary intake of toxic elements. The FDA has communicated risks by issuing the risk assessment and draft guidance on arsenic in infant rice cereal, but has not updated or finalized these documents. The USDA has communicated the results of their research through presentations at conferences and through outreach to farmers, including in cooperation with extension programs at universities.

Coordination. The FDA coordinated with several federal agencies on the development of the risk assessment and draft guidance on arsenic in infant rice cereal. It then reached out to the USDA for input on how to reduce the levels of arsenic in rice during the growing process and the feasibility of industry meeting its draft guidance. Other agencies reported that they were generally satisfied with the FDA’s coordination efforts and the extent to which the FDA addressed their comments. However, the USDA asserted that it had relevant scientific and technical expertise that should have played a role in developing the risk assessment.

The FDA and USDA coordinated on the development of detection methods, but only to a limited extent. The USDA agencies felt that the different agencies were trying to meet different needs with their research and coordination was unnecessary, however the GAO believed that by coordinating efforts, the agencies could enhance the ability to use resources effectively and avoid engaging in unnecessary and potentially duplicative efforts.

Recommendations. The GAO recommends that the FDA develop a timeline for updating the risk assessment on arsenic in rice and a timeline for finalizing the draft guidance on arsenic in infant rice cereal. Additionally, the FDA should develop a mechanism for working with relevant agencies to identify their roles and responsibilities for coordinating risk assessments of contaminants in food, including arsenic in rice. Finally, the FDA and USDA should work together to develop a mechanism to coordinate the development of methods to detect contaminants in food, including arsenic in rice.

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